Actinogen reports more positive results in XanCIDD phase 2a depression trial

Actinogen Medical (ACW), an Australian biotech firm, has reported significant findings from its ongoing XanaCIDD Phase 2a trial, highlighting the efficacy of its drug Xanamem® in treating symptoms of depression. Xanamem is shown to be effective in controlling brain cortisol levels, which is linked to its anti-depressant activity.

Key findings from the updated results include a confirmed improvement in the MADRS depression score, with significant effects observed in five out of six pre-specified subgroups, suggesting a broad impact across various patient profiles. Further analysis of the Patient Global Impression of Severity (PGI-S) supports these findings, showing consistent benefits that align with the MADRS data. Moreover, new responder analyses of the MADRS scores indicate a higher rate of depression remission by 50% at Week 10 for those treated with Xanamem.

The maximal benefits on depressive symptoms were observed at Week 10, four weeks after completing the treatment, indicating a durable therapeutic effect. This durability is attributed to Xanamem's ability to control underlying stress-related biological processes in the brain by modifying gene expression and protein synthesis due to its action on cortisol.

According to Actinogen, these findings underscore the clinically significant activity of Xanamem's novel mechanism in treating Major Depressive Disorder (MDD). The company is currently engaging with regulators, global experts, and potential strategic partners to explore further development in MDD.

Dr. Steven Gourlay, CEO of Actinogen, expressed optimism about the results, emphasizing the significant clinical impact of Xanamem’s cortisol control mechanism in the brain. He noted that a daily 10 mg dose of Xanamem could potentially serve as an effective anti-depressant with a unique action profile. Additionally, the safety profile of Xanamem sets it apart from other treatments in the competitive anti-depressant market.

Dr. Gourlay also highlighted the potential benefits of Xanamem in treating depressive symptoms associated with Alzheimer's disease. Current efforts are concentrated on the XanaMIA Phase 2b trial, which aims to assess Xanamem's effects on slowing or halting the progression of Alzheimer's over a 36-week period, with interim data expected by mid-2025.

Further exploration of secondary endpoints and subgroup analyses from the XanaCIDD trial revealed that Xanamem not only improved MADRS depression scores across all 165 patients but also showed benefits in five out of six subgroups. The PGI-S analysis confirmed clinically significant benefits at Week 10, coinciding with the MADRS observations.

Details of the XanaCIDD Phase 2a trial design include a randomized, double-blind, placebo-controlled, parallel group, six-week study involving 167 patients with persistent MDD and measurable cognitive impairment. Participants received either Xanamem 10 mg or placebo, with the primary endpoint being the computerized Cogstate Attention Composite test battery, and the key secondary endpoint being the MADRS.

Actinogen Medical is a biotechnology company focused on developing therapies for neurological and neuropsychiatric disorders linked to dysregulated brain cortisol. The company’s lead compound, Xanamem, is being investigated for its potential to treat Alzheimer's Disease and Depression, with plans to study Fragile X Syndrome and other conditions in the future.

Current clinical trials include XanaCIDD, assessing Xanamem's impact on cognition and depression, and XanaMIA, a Phase 2b trial evaluating Xanamem's effects on Alzheimer's disease progression. Xanamem's novel mechanism involves blocking cortisol production in brain cells, which is believed to contribute to its therapeutic potential.

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